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- Title
Comparative Study of the Selectivity Power of Colorimetric Method Over Chromatographic Methods for the Analysis of Valaciclovir Hydrochloride.
- Authors
Morgan, Eman M.; Lotfy, Hayam Mahmoud; Fayez, Yasmin Mohammed; Abdelkawy, Mohamed
- Abstract
Background: Valaciclovir hydrochloride (VAL) is an essential antiviral prodrug used to cure various types of herpes. Analysis of VAL by different analytical techniques demonstrates a persuasive aspect that is favorable in quality control application. Objective: This study describes a comparison between colorimetric and chromatographic (RP-high performance liquid chromatography (HPLC) and thin-layer chromatography (TLC)-densitometric) methods concerning selectivity and specificity for the determination of VAL in all possible degradation products (alkali- and acid-induced degradation products, namely aciclovir [ACI] and guanine [GUA], respectively) in their synthetic mixture and pharmaceutical formulations. Method: The colorimetric method was accomplished by forming a highly colored complex with ferric hydroxamate reagent measured at 493nm in the concentration range (0.20-1.60mg/mL). Both chromatographic methods were successfully applied using ultraviolet (UV) detection at 256nm in the concentration range (2.00-5.00 mg/mL) for the RP-HPLC method and (10.00-900.00 ng/band) for the TLC-densitometric method. Results: The linearity studies, regression equations, assay parameters, and validation sheet of the proposed colorimetric and chromatographic methods to determine VAL were obtained with highly acceptable values. Conclusions: The International Council for Harmonization (ICH) guidelines were followed to validate the described methods and the statistical comparison regarding both accuracy and precision, and satisfactory results were accomplished. Highlights: In this study, we configure a full comparative study between different analytical methods for the analysis of challengeable mixture containing the drug of interest, VAL, along with its degradation products, ACI and GUA.
- Subjects
CHROMATOGRAPHIC analysis; VALACYCLOVIR; LIQUID chromatography; COMPARATIVE studies; QUALITY control
- Publication
Journal of AOAC International, 2022, Vol 105, Issue 3, p717
- ISSN
1060-3271
- Publication type
Article
- DOI
10.1093/jaoacint/qsab170